Government Chemist
The European Court of Justice has, in a landmark ruling, said the 0.1 % threshold for notifying Substances of Very High Concern in articles applies to each of the articles incorporated as a component of a complex product rather than to the entire article. An article is generally understood to be an object composed of one or more substances or mixtures given a specific shape, surface or design.
This has been a matter of both controversy and discussion for several years, with EU Member States being divided between those who agree with the ruling and those who believe that the 0.1 % threshold applies to the complete product.
The court said the REACH Regulations definition of an article, taken together with the lack of any provisions specifically addressing the situation of a complex product containing several articles, means there is no need to draw a distinction between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner.Thus, each of the articles, incorporated as a component of a complex product, is covered by the relevant duties to notify and provide information, when they contain an SVHC in a concentration above 0.1 % of their mass. So, to clarify, if one component of a product contains >0.1% of one or more SVHCs then the final product has to be labelled, even if the concentration of SVHC in final product formulation is <0.1 %.
This clarifies the situation for manufacturers, importers and downstream users, as well as providing laboratories testing these products on behalf of manufacturers and regulators with clarity on what needs to be tested and at what levels. The presence of a substance registered under REACH at a concentration of 0.1 % in a minor component of a product will therefore be at a significantly lower concentration in the overall product, which will require laboratories to have validated procedures in place to measure these substances at the appropriate concentrations with an acceptable measurement uncertainty.